GULFTENE C16-18 ISOMERISED OLEFINS - NICNAS

Pathology:
F0 males and satellite females:
Organ Weights:
Significantly increased absolute liver weight and liver weight relative to brain weight in
animals of the 500 and 1 000 mg/kg/day group.
Significant findings in females only were decreased spleen weight (relative to brain
weights) in the 1 000 mg/kg/day group and increased kidney weight in the 500 mg/kg/day
group.
Macroscopic:
In males, pitted kidneys were observed in the 500 and 1 000 mg/kg/day groups.
Microscopic:
Treatment related effects were observed in kidneys of all test males (dose-related increased
eosinophillic hyaline droplets in the proximal convoluted tubules, a finding commonly
associated with hydrocarbon nephropathy). Minimal to moderate hepatocellular
vacuolation was observed in animals of the 500 and 1 000 mg/kg/day groups.
F0 females:
Macroscopic:
No test related findings were observed. The animal euthanised on post breeding Day 25
was found to be non gravid. The animal euthanised on Day 43 was found to have
implantation sites.
Fertility, Gestation, Parturition and Lactation:
Mating and fertility indices, precoital intervals and gestation length were comparable
among the groups.
F1 generation findings:
No treatment related developmental effects through to lactation Day 4.
Result:
Based upon liver weight increase and hepatocyte cytoplasmic vacuolation observed at 500
and 1 000 mg/kg/day, the No Observed Adverse Effect Level (NOAEL) determined for
systemic toxicity in satellite females was 100 mg/kg/day. No NOAEL for systemic toxicity
was established for males because of the presence of hydrocarbon nephropathy noted at all
dose levels. The NOAEL for reproductive developmental or neurotoxicity was 1 000
mg/kg/day in both males and females.
9.2.4 Repeat Dose 13 Week Oral Toxicity Study in Rats Followed by a 4 Week
Recovery Period using C20-C24 Alkenes, Branched and Linear (Huntingdon Life
Sciences Limited 1999)
Test Substance: C20-C24 Alkenes, Branched and Linear
Species/strain: Rat/Crl:CD BR
Method of administration: Oral (gavage)
Dose/Study duration: 0, 100, 500, 1 000 mg/kg/day for 13 weeks followed by a
FULL PUBLIC REPORT 26 April 2000
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